IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes

PurposeTo study, from a U.S. payer’s perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae.Materials and MethodsCost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated.ResultsUsing the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48.ConclusionsEndovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.     

SHEL模式下基层医院护理人员高警示药品安全管理培训的效果

目的:探究SHEL模式下基层医院护理人员高警示药品安全管理培训的效果。方法:选取2020年7月—2021年6月在医院从事临床护理工作的80名护理人员,随机将其分为观察组与对照组各40人。对照组实施常规培训模式,观察组实施SHEL模式培训,比较两组护理人员高警示药品相关知识及技能掌握程度、意外事件发生率及核心能力。结果:培训后观察组护理人员理论及操作得分分别为(86.75±6.18)分及(93.19±4.28)分,核心能力得分为(228.98±8.37)分,均明显高于对照组(P<0.05),同时观察组护理人员在护理过程中出现给药前未双人核对、药品分类不清及交接记录不全的概率分别为0.95%、0.95%及1.90%,明显低于对照组(P<0.05),且未出现药物外渗及滴速有误等情况。结论:对基层医院护理人员实施SHEL模式下高警示药品安全管理培训,能够有效提高护理人员高警示药品理论、技能掌握程度及核心能力,同时有助于降低护理工作中意外事件的发生概率。     

Time-varying association of second primary malignancy and long-term survival outcomes in patients with head and neck cancer

A high risk of developing second primary malignancy (SPM) has been reported among head and neck cancer patients. Here, we aimed to statistically quantify the impact of SPM development on the survival of head and neck cancer patients. Our study was conducted using the Surveillance, Epidemiology and End Results database to collect the data of 48 316 patients who received curative surgical resection for initial primary head and neck squamous cell carcinoma (IP-HNSCC) in 1975 to 2019. SPM diagnosis was treated as a time-varying covariate and multivariable Cox regression analysis was conducted to estimate the association between SPM development and survival, overall or by the subsite of IP-HNSCC. Of the included patients, 11 238 patients (23.3%) developed SPM during the follow-up period. A significant reduction in survival was observed among patients with SPM (hazard ratio [HR] for overall survival, 3.30; 95% confidence interval [CI]: 3.20-3.41). The impact of SPM development on reduced survival was more significant in patients with localized IP-HNSCC vs regional IP-HNSCC (HR_OS, 3.41; 95% CI: 3.24-3.6 vs HR_OS, 3.18; 95% CI: 3.05-3.31; P for interaction <.001). The survival impact of SPM development was more evident in younger patients than in older patients. SPM in lung and bronchus was associated with the most pronounced reduction in survival, overall and across all subsites of HNSCC. Our results indicated that SPM development led to a significant reduction in survival. A greater survival benefit may be achieved through intensive surveillance for SPM in lung and bronchus targeting younger patients and those with localized HNSCC.     

原发性闭角型青光眼合并视网膜色素变性的临床特征分析

目的 分析原发性闭角型青光眼合并视网膜色素变性患者的临床特征。 方法 本研究纳入2013年4月至2017年4月于首都医科大学附属北京同仁医院眼科中心住院治疗的原发性闭角型青光眼(primary angle closure glaucoma ,PACG)合并视网膜色素变性(retinitis pigmentosa,RP)患者32例,和同期入院的不合并RP的PACG患者229例。根据青光眼类型将其分为4组,急性闭角型青光眼合并RP组(acute angle closure glaucoma with retinitis pigmentosa, AACG-RP)12例、慢性闭角型青光眼合并RP组(chronic angle closure glaucoma with retinitis pigmentosa, CACG-RP)20例、急性闭角型青光眼不合并RP组(AACG-non RP)94例、慢性闭角型青光眼不合并RP组(CACG-non RP)135例,比较4组患者的发病年龄和眼轴长度等参数。 结果 患者平均发病年龄AACG-RP组(39.00±12.07)岁、CACG-RP组(43.85±12.79)岁、AACG-non RP组(66.44±9.40)岁、CACG-non RP组(63.95±10.42)岁,4组之间差异有统计学意义(F=47.70,P<0.05)。患者平均眼轴长度AACG-RP组(21.31±1.37)mm、CACG-RP组(22.33±1.09)mm、AACG-non RP组(22.31±1.03)mm、CACG-non RP组(22.47±1.01)mm,4组之间差异有统计学意义(F=19.09,P<0.05)。 结论 原发性闭角型青光眼患者合并视网膜色素变性患者中,急性闭角型青光眼患者较慢性闭角型青光眼患者发病更早,眼轴更短。原发性闭角型青光眼合并视网膜色素变性患者,尤其是急性闭角型青光眼合并视网膜色素变性患者较无视网膜色素变性者发病年龄更早,且眼轴更短。     

Treating insomnia in Swiss primary care practices: A survey study based on case vignettes

Guidelines recommend cognitive behavioural therapy for insomnia (CBT‐I) as first‐line treatment for chronic insomnia, but it is not clear how many primary care physicians (PCPs) in Switzerland prescribe this treatment. We created a survey that asked PCPs how they would treat chronic insomnia and how much they knew about CBT‐I. The survey included two case vignettes that described patients with chronic insomnia, one with and one without comorbid depression. PCPs also answered general questions about treating chronic insomnia and about CBT‐I and CBT‐I providers. Of the 820 Swiss PCPs we invited, 395 (48%) completed the survey (mean age 54 years; 70% male); 87% of PCPs prescribed sleep hygiene and 65% phytopharmaceuticals for the patient who had only chronic insomnia; 95% prescribed antidepressants for the patient who had comorbid depression. In each case, 20% of PCPs prescribed benzodiazepines or benzodiazepine receptor agonists, 8% prescribed CBT‐I, 68% said they knew little about CBT‐I, and 78% did not know a CBT‐I provider. In the clinical case vignettes, most PCPs treated chronic insomnia with phytopharmaceuticals and sleep hygiene despite their lack of efficacy, but PCPs rarely prescribed CBT‐I, felt they knew little about it, and usually knew no CBT‐I providers. PCPs need more information about the benefits of CBT‐I and local CBT‐I providers and dedicated initiatives to implement CBT‐I in order to reduce the number of patients who are prescribed ineffective or potentially harmful medications.     

Good mid-term outcome of the rotating hinge knee in primary total knee arthroplasty – Results of a single center cohort of 106 knees with a median follow-up of 6.3 years

BackgroundThe prognosis of complex primary total knee arthroplasty (TKA) with severe deformity and ligament deficiency is not clear. There is a paucity of evidence in the current literature on treatment outcomes of the rotating hinge knee implants in primary TKA. The aim of this study was to determine the mid-term clinical, radiographic, and health-related quality of life (HRQoL) outcomes in patients who had undergone complex primary TKA using single hinged knee replacement.MethodsIn total, 106 complex primary TKAs (101 patients) were performed using the single rotating hinged knee (RHK) implant design at our institution between January 2004 and December 2013. We conducted a retrospective analysis of prospectively collected outcome data of these patients, obtaining also information on all possible revision surgeries from the Finnish Arthroplasty Register, and conducted a prospective follow-up study of all living patients.ResultsThe 10-year Kaplan-Meier survival rate of the RHK knees was 91.6% (95% CI 86.0% to 97.2%) with revision for any reason as the endpoint. Overall, eight knees (7.5 %) underwent revision surgery during the follow-up. None of the unrevised RHK knees were radiographically loose. The majority of patients evinced good clinical outcome and quality of life as measured with patient reported outcome measures.ConclusionThe hinge knee replacement which was assessed current study can be regarded as a suitable option in complex primary TKA, provided adequate attention is paid to the correct indications and patient selection.